Neumora Therapeutics Announces Initiation of Phase 1 Clinical Study of M4 Positive Allosteric Modulator NMRA-861
Neumora Therapeutics (Nasdaq: NMRA) has initiated a Phase 1 single-ascending dose/multiple-ascending dose (SAD/MAD) study of NMRA-861, a highly potent and selective M4 positive allosteric modulator (PAM), in healthy adults and those with stable schizophrenia.
The drug candidate demonstrates potential best-in-class pharmacology and showed promising safety in pre-clinical studies with no convulsions observed across multiple species. The company expects to report Phase 1 data, including safety, tolerability, and pharmacokinetic results, in Q1 2026.
NMRA-861 aims to offer a differentiated treatment option for schizophrenia and other neuropsychiatric disorders, potentially providing improved therapeutic benefits compared to current antipsychotics and non-selective muscarinic agonists, with the possibility of once-daily dosing.
Neumora Therapeutics (Nasdaq: NMRA) ha avviato uno studio di Fase 1 a dose singola ascendente/dose multipla ascendente (SAD/MAD) su NMRA-861, un modulatore allosterico positivo (PAM) altamente potente e selettivo del recettore M4, in adulti sani e in pazienti con schizofrenia stabile.
Il candidato farmaco mostra una farmacologia potenzialmente best-in-class e ha evidenziato un profilo di sicurezza promettente negli studi pre-clinici, senza convulsioni osservate in diverse specie. L'azienda prevede di comunicare i dati di Fase 1, inclusi sicurezza, tollerabilità e risultati farmacocinetici, nel primo trimestre 2026.
NMRA-861 punta a offrire un'opzione terapeutica differenziata per la schizofrenia e altri disturbi neuropsichiatrici, con il potenziale di fornire benefici terapeutici migliorati rispetto agli antipsicotici attuali e agli agonisti muscarinici non selettivi, con la possibilità di una somministrazione una volta al giorno.
Neumora Therapeutics (Nasdaq: NMRA) ha iniciado un estudio de Fase 1 con dosis única ascendente/dosis múltiples ascendentes (SAD/MAD) de NMRA-861, un modulador alostérico positivo (PAM) altamente potente y selectivo del receptor M4, en adultos sanos y en personas con esquizofrenia estable.
El candidato a medicamento demuestra una farmacología potencialmente líder en su clase y mostró seguridad prometedora en estudios preclínicos, sin convulsiones observadas en múltiples especies. La compañía espera reportar los datos de Fase 1, incluidos seguridad, tolerabilidad y resultados farmacocinéticos, en el primer trimestre de 2026.
NMRA-861 busca ofrecer una opción de tratamiento diferenciada para la esquizofrenia y otros trastornos neuropsiquiátricos, con el potencial de proporcionar beneficios terapéuticos mejorados en comparación con los antipsicóticos actuales y los agonistas muscarínicos no selectivos, con la posibilidad de una dosificación diaria.
Neumora Therapeutics (나스닥: NMRA)는 건강한 성인과 안정된 정신분열증 환자를 대상으로 NMRA-861의 1상 단일 상승 용량/다중 상승 용량(SAD/MAD) 시험을 시작했습니다. NMRA-861은 매우 강력하고 선택적인 M4 양성 알로스테릭 조절제(PAM)입니다.
이 약물 후보는 잠재적으로 최고 수준의 약리 효과를 보이며, 다종에서 경련이 관찰되지 않은 유망한 안전성을 전임상 시험에서 입증했습니다. 회사는 2026년 1분기에 안전성, 내약성 및 약동학 결과를 포함한 1상 데이터를 보고할 예정입니다.
NMRA-861은 정신분열증 및 기타 신경정신 질환에 대해 차별화된 치료 옵션을 제공하고, 기존 항정신병 약물 및 비선택적 무스카린 작용제보다 개선된 치료 혜택을 제공하며 하루 1회 투여 가능성을 갖는 것을 목표로 합니다.
Neumora Therapeutics (Nasdaq : NMRA) a lancé une étude de phase 1 avec doses uniques ascendantes/doses multiples ascendantes (SAD/MAD) de NMRA-861, un modulateur allostérique positif (PAM) M4 hautement puissant et sélectif, chez des adultes en bonne santé et des patients atteints de schizophrénie stable.
Le candidat-médicament présente une pharmacologie potentiellement best-in-class et a montré une sécurité prometteuse dans des études précliniques, sans convulsions observées chez plusieurs espèces. La société prévoit de communiquer les données de phase 1, incluant la sécurité, la tolérance et les résultats pharmacocinétiques, au 1er trimestre 2026.
NMRA-861 vise à offrir une option thérapeutique différenciée pour la schizophrénie et d'autres troubles neuropsychiatriques, avec un potentiel d'amélioration des bénéfices thérapeutiques par rapport aux antipsychotiques actuels et aux agonistes muscariniques non sélectifs, avec la possibilité d'une administration quotidienne.
Neumora Therapeutics (Nasdaq: NMRA) hat eine Phase-1-Studie mit Einzel- und mehrfach ansteigender Dosis (SAD/MAD) von NMRA-861, einem hochpotenten und selektiven M4-positiven allosterischen Modulator (PAM), bei gesunden Erwachsenen und Patienten mit stabiler Schizophrenie eingeleitet.
Der Wirkstoffkandidat zeigt potenziell erstklassige Pharmakologie und wies in präklinischen Studien eine vielversprechende Sicherheit ohne beobachtete Krampfanfälle in mehreren Spezies auf. Das Unternehmen erwartet, die Phase-1-Daten, einschließlich Sicherheit, Verträglichkeit und pharmakokinetischer Ergebnisse, im 1. Quartal 2026 zu berichten.
NMRA-861 zielt darauf ab, eine differenzierte Behandlungsoption für Schizophrenie und andere neuropsychiatrische Erkrankungen zu bieten, die möglicherweise verbesserte therapeutische Vorteile gegenüber aktuellen Antipsychotika und nicht-selektiven muskarinischen Agonisten bietet, mit der Möglichkeit einer einmal täglichen Dosierung.
- Potential best-in-class pharmacology with high potency and selectivity
- No convulsions observed in pre-clinical toxicology studies across multiple species
- Demonstrated robust activity in preclinical efficacy models
- Potential for once-daily dosing administration
- Phase 1 data results won't be available until Q1 2026
- Early-stage development with no human efficacy data yet
Insights
Neumora advances potential best-in-class schizophrenia treatment into Phase 1 trials, with favorable preclinical safety profile and data expected Q1 2026.
Neumora's advancement of NMRA-861 into clinical testing represents a significant milestone in their CNS-focused pipeline. This M4 muscarinic receptor positive allosteric modulator (PAM) has demonstrated several compelling preclinical characteristics that differentiate it from existing schizophrenia treatments and other muscarinic modulators in development.
The company has highlighted three key potential advantages: best-in-class pharmacology, favorable safety profile with no convulsions observed in multiple animal species (notably including rabbits), and pharmacokinetics potentially supporting once-daily dosing. The absence of convulsions in preclinical studies is particularly noteworthy, as this has been a limiting toxicity for other muscarinic modulators.
From a mechanistic perspective, targeting the M4 receptor's allosteric site offers potential advantages over traditional antipsychotics. By modulating both cholinergic and dopamine signaling through this selective approach, NMRA-861 may address both positive and negative symptoms of schizophrenia while avoiding the problematic side effects that plague current therapies and lead to treatment discontinuation.
For investors, the expected Phase 1 data readout in Q1 2026 provides a clear milestone to evaluate NMRA-861's human safety profile and confirmation of CNS penetration. The compound is part of Neumora's broader neuroscience pipeline comprising seven programs, with three already in clinical stages, positioning the company as a focused player in addressing significant unmet needs in brain disorders.
NMRA-861 has potential best-in-class pharmacology, which may enable a more favorable therapeutic profile
No convulsions observed in pre-clinical studies conducted in multiple species, including rabbits
WATERTOWN, Mass., July 09, 2025 (GLOBE NEWSWIRE) -- Neumora Therapeutics, Inc. (Nasdaq: NMRA), a clinical-stage biopharmaceutical company with a therapeutics pipeline consisting of seven brain disease programs including three clinical-stage programs, today announced the initiation of a Phase 1 single-ascending dose/multiple-ascending dose (SAD/MAD) study of NMRA-861 in healthy adult participants and adults with stable schizophrenia. NMRA-861 is a highly potent and selective positive allosteric modulator (PAM) of the M4 muscarinic receptor with potential best-in-class pharmacology that Neumora is developing for the treatment of schizophrenia and other neuropsychiatric disorders. Neumora expects to report data from the Phase 1 SAD/MAD study in the first quarter of 2026, including safety and tolerability, and human pharmacokinetic data confirming the potential for once-daily dosing and central nervous system penetration.
“NMRA-861 has potential as a differentiated treatment option across multiple indications and may offer an improved therapeutic profile relative to current antipsychotics and other non-selective muscarinic agonists,” said Nick Brandon, Ph.D., chief scientific officer, Neumora. “The initiation of the Phase 1 SAD/MAD study with NMRA-861 is an important step for our M4 franchise, and we look forward to reporting data from this study next year.”
NMRA-861 has demonstrated a potentially best-in-class pharmacological profile and robust activity in preclinical efficacy models. NMRA-861 was safe and well-tolerated in pre-clinical toxicology studies and no convulsions have been observed in rabbits, dogs and rats.
“Schizophrenia is a complex and serious disorder. Although antipsychotic agents are the cornerstone of treatment for schizophrenia, their effectiveness is limited, leaving many patients symptomatic despite ongoing antipsychotic therapy. Additionally, medication-related side effects and non-adherence remain key obstacles in treating patients,” said Dr. Christoph Correll, Clinical Professor of Psychiatry, Zucker School of Medicine at Hofstra/Northwell, NY, and Professor of Child and Adolescent Psychiatry, Charité University Medicine, Berlin, Germany. “Targeting M4 receptors is a highly promising approach to treating schizophrenia, and emerging evidence indicates that targeting the allosteric binding site allows for greater selectivity for the M4 receptor, which may lead to a more favorable therapeutic profile, including tolerability and once-daily dosing. The potential for M4 PAMs to modulate cholinergic and dopamine signaling without the side effects of traditional antipsychotics opens a compelling new chapter in the treatment of schizophrenia and other serious neuropsychiatric conditions. Expanding the range of treatment options for patients and clinicians is essential to addressing this critical unmet need.”
About NMRA-861
NMRA-861 is an investigational positive allosteric modulator of the M4 muscarinic receptor subtype. Neumora exclusively licensed certain intellectual property rights related to NMRA-861 from the Warren Center for Neuroscience Drug Discovery at Vanderbilt University, including a composition of matter patent extending to 2044 excluding any patent term adjustment or extension. While most current antipsychotics approved for schizophrenia work primarily by blocking D2 dopamine receptors, growing evidence supports the approach of targeting the M4 muscarinic receptor to elicit antipsychotic effects, without the side effects associated with the first- and second-generation antipsychotics. M4 muscarinic receptor-targeting compounds have shown robust antipsychotic activity in multiple, placebo-controlled clinical trials, demonstrating potential as an approach to treating schizophrenia. NMRA-861 has demonstrated a best-in-class pre-clinical profile in studies which were completed at the Warren Center for Neuroscience Drug Discovery at Vanderbilt University.
About Schizophrenia
Schizophrenia is a debilitating neuropsychiatric disorder characterized by positive symptoms (such as delusions and hallucinations), negative symptoms (such as diminished emotional expression) and cognitive symptoms (such as deficits in types of memory) that impacts approximately 3 million adults in the United States. Significant unmet medical need remains as many currently approved therapies for schizophrenia may be associated with serious side effects, including extrapyramidal symptoms and cardiometabolic effects. In fact, a study conducted by the National Institute of Mental Health found that approximately 75 percent of people with schizophrenia discontinue medication within 18 months due in part to inefficacy or intolerable side effects.
About Neumora
Neumora Therapeutics, Inc. is a clinical-stage biopharmaceutical company founded to confront the global brain disease crisis by taking a fundamentally different approach to the way treatments for brain diseases are developed. Our therapeutic pipeline currently consists of seven neuroscience programs that target novel mechanisms of action for a broad range of underserved neuropsychiatric disorders and neurodegenerative diseases. Our work is supported by an integrated suite of translational, clinical and computational tools to generate insights that can enable precision medicine approaches. Neumora’s mission is to redefine neuroscience drug development by bringing forward the next generation of novel therapies that offer improved treatment outcomes and quality of life for patients suffering from brain diseases.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements about Neumora Therapeutics, Inc. (the “Company,” “we,” “us,” or “our”) within the meaning of the federal securities laws, including statements related to: Neumora’s intention to redefine neuroscience drug development by bringing forward the next generation of novel therapies that offer improved treatment outcomes and quality of life for patients suffering from brain diseases; the timing, progress and plans for its therapeutic development programs, including the NMRA-861 Phase 1 study, best-in-class pharmacology and the potential of M4 PAMs; the potential for Neumora to advance other compounds in its M4 portfolio; intellectual property protection and other statements identified by words such as “could,” “expects,” “intends,” “may,” “plans,” “potential,” “should,” “will,” “would,” or similar expressions and the negatives of those terms. Other than statements of historical facts, all statements contained in this press release are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These statements are subject to risks and uncertainties that could cause the actual results to be materially different from the information expressed or implied by these forward-looking statements, including, among others: the risks related to the inherent uncertainty of clinical drug development and unpredictability and lengthy process for obtaining regulatory approvals; risks related to the timely initiation and enrollment in our clinical trials; risks related to our reliance on third parties, including contract research organizations; risks related to serious or undesirable side effects of our therapeutic candidates; risks related to our ability to utilize and protect our intellectual property rights; and other matters that could affect sufficiency of capital resources to fund operations. For a detailed discussion of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Neumora’s business in general, please refer to the risk factors identified in the Company’s filings with the Securities and Exchange Commission (SEC), including but not limited to its Quarterly Report on Form 10-Q for the quarter ended March 31, 2025 which was filed with the SEC on May 12, 2025. Forward-looking statements speak only as of the date hereof, and, except as required by law, Neumora undertakes no obligation to update or revise these forward-looking statements.
Neumora Contact
Helen Rubinstein
617-402-5700
Helen.Rubinstein@neumoratx.com
FAQ
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